[Federal Register: April 19, 2004 (Volume 69, Number 75)]
[Rules and Regulations]
[Page 20805-20809]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap04-1]
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Rules and Regulations
Federal Register
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[[Page 20805]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 77
[Docket No. 02-112-3]
Tuberculosis in Cattle and Bison; State and Zone Designations;
Michigan
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the bovine tuberculosis regulations by
establishing two separate zones with different tuberculosis risk
classifications in the State of Michigan and raising the designation of
one of those zones from modified accredited to modified accredited
advanced.
We are taking this action based on our determination that Michigan
meets the requirements for zone recognition and that one of the zones
meets the criteria for designation as modified accredited advanced.
EFFECTIVE DATE: April 19, 2004.
FOR FURTHER INFORMATION CONTACT: Dr. Terry Beals, Senior Staff
Veterinarian, Eradication and Surveillance Team, National Center for
Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale,
MD 20737-1231; (301) 734-5467.
SUPPLEMENTARY INFORMATION:
Background
The regulations contained in 9 CFR part 77, ``Tuberculosis''
(referred to below as the regulations), and the ``Uniform Methods and
Rules-Bovine Tuberculosis Eradication'' (UMR), which is incorporated by
reference into the regulations, restrict the interstate movement of
cattle, bison, and captive cervids to prevent the spread of
tuberculosis.
On April 7, 2003, we published in the Federal Register (68 FR
16733-16735, Docket No. 02-112-1) a proposal to amend the bovine
tuberculosis regulations by establishing two separate zones with
different risk classifications in the State of Michigan and raising the
designation of one of those zones from modified accredited to modified
accredited advanced.
We solicited comments concerning our proposal for 60 days ending
June 6, 2003. We reopened the comment period and extended the deadline
for comments until July 25, 2003, in a document published in the
Federal Register on June 25, 2003 (68 FR 37774, Docket No. 02-112-2).
We received 77 comments by the close of the extended comment period.
They were from State and local government officials, livestock
producers, industry associations, veterinarians, and a consumer
organization. We have carefully considered all of the comments we
received. They are discussed below by topic.
Note: Shortly after the proposed rule was published, a
tuberculosis-infected beef cow was discovered in Antrim County,
which was one of the counties included in the proposed modified
accredited advanced zone. The affected herd has been depopulated,
and a complete epidemiological investigation into the potential
sources of the disease was conducted. However, because of that
finding, we have removed Antrim County from the modified accredited
advanced zone in this final rule, and that county will retain its
current modified accredited status. Also, due to its inseparability
from the modified accredited area (i.e., it is surrounded on three
sides by modified accredited counties), we have removed Charlevoix
County from the modified accredited advanced zone in this final
rule; that county will also retain its current modified accredited
status. We anticipate that, given the nature of Michigan's bovine
tuberculosis eradication program, Antrim and Charlevoix Counties, as
well as Emmet County, will be the first counties in the modified
accredited zone that will become eligible for increased bovine
tuberculosis status under the standards set forth in Sec. 77.11(f)
and the UMR, given that the current infection levels in those
counties are much lower than the infection levels throughout the
rest of the modified accredited zone.
Boundary Designation
One commenter suggested that the AuSable River, being a more
impenetrable natural boundary than the Huron National Forest, is a
better choice for defining the southernmost edge of the modified
accredited zone.
Under Sec. 77.4(a), separate zones of bovine tuberculosis
classification within a State must be delineated by the animal health
authorities in the State making the request for zone recognition,
subject to approval by the Animal and Plant Health Inspection Service
(APHIS). The division as outlined in our proposed rule was that
developed by Michigan in accordance with the regulations in Sec. Sec.
77.3 and 77.4. Another of Michigan's proposed alternatives would have
utilized the AuSable River as a boundary as suggested by the commenter.
Our review team, consisting of representatives of State and Federal
agricultural agencies as well as private contractors, considered each
option and ultimately recommended against the use of the AuSable River
as a boundary since it may be forded easily during certain periods of
the year. We believe that the Huron National Forest is a better choice,
since it is a fairly vast expanse of uninhabited land where deer are
not drawn together unnaturally through feeding and baiting.
Another commenter said that the best way to achieve split State
status is to utilize the Great Lakes as a boundary, designating the
Upper Peninsula as modified accredited advanced and the Lower Peninsula
as modified accredited.
Geographically, we agree that a division utilizing the Great Lakes
as a boundary would be desirable and effective. The 15 counties in
Michigan's Upper Peninsula are included in the modified accredited
advanced zone, however, there are 55 counties in the Lower Peninsula
that meet our requirements for modified accredited advanced status.
Exclusion from the modified accredited advanced zone of cattle
producers, processors, and associated entities in those 55 counties
solely on the basis of geographical factors would not be appropriate in
our view.
One commenter stated that since bovine tuberculosis has been
detected in free-ranging deer in Mecosta, Osceola, and Antrim Counties,
these counties should be included in the zone designated as modified
accredited. The commenter additionally said that the dividing line
between the modified accredited and modified accredited advanced zones
should lie at the
[[Page 20806]]
northern boundaries of Oceana, Newaygo, Mecosta, Isabella, Midland, and
Bay Counties.
The incidence of free ranging deer testing positive for bovine
tuberculosis in Mecosta and Osecola Counties is a total of one per
county during the nine years that sampling has occurred. Such a rate
does not justify alteration of the proposed boundaries to include 14
additional counties and their associated producers, livestock, and
related industries. As previously stated, in this final rule, we are
expanding the modified accredited zone beyond what was proposed to also
include Antrim and Charlevoix Counties.
Another commenter said that the zone division should occur solely
along county lines since it will prove difficult for those receiving
cattle in other States to determine from which part of the divided
counties those cattle originated.
Much of the boundary is defined by county lines, with the exception
of the southern boundary line in Iosco and Ogemaw Counties, which
utilizes the Huron National Forest and the Au Sable State Forest. We
have determined that the use of State and Federal forest land is the
best boundary option in this case, since it serves as a far more
impenetrable boundary than an imaginary county line.
Wild Deer Controls
Several commenters stated that, before split State status is
granted, there needs to be more done on a statewide basis to eliminate
tuberculosis in the wild deer population and decrease the wild deer
population as a whole. The commenters further said that splitting the
State into two zones of classification would exacerbate the problem
since the relatively small size of the modified accredited area will
provide no incentive for such disease elimination or depopulation
initiatives.
Much is being accomplished to control bovine tuberculosis in
wildlife reservoirs. The boundaries as described in this final rule
include a vast area of forest land, which will facilitate existing
wildlife control programs. In our view, rather than resulting in
reduction of attention and financial resources, the relatively small
size of the modified accredited area will allow available resources to
be concentrated and applied to a localized area, thus increasing the
efficacy of the programs.
One commenter said that split State status should not be considered
since the tuberculosis infection rates in sampled deer have not
declined, but remained static, and infection rates have increased for
yearling deer.
While we recognize that both of the commenter's points are correct
with regard to infection levels in deer for 2002, we do not consider
the figures, especially the increase in tuberculosis among yearling
deer, to be significant. Recently released statistics for 2003 show
that the prevalence of bovine tuberculosis in all classes of deer,
including yearling deer, declined in 2003. In addition, the relatively
small increase in previous infection levels makes it difficult to
determine what factors may have led to the situation as described by
the commenter. Included in our requirements for maintenance of zones
within States found at Sec. 77.4(a)(3), a State is required to
maintain or improve the tuberculosis classification of lower status
areas. However, the maintenance or improvement is required to be shown
in the domestic livestock population only, not in wildlife. Among the
factors we consider as improvement are lowering the level of
tuberculosis infection in whitetail deer and reducing the number of
transmissions from wildlife to cattle. These requirements serve to
ensure that tuberculosis eradication programs within States are
preserved. In the long run, this approach may help States by allowing
funds to be focused on smaller problem areas.
Eradication Programs
Several commenters were concerned with the discovery of the bovine
tuberculosis infected herd in Antrim County. They asked that a full
investigation be conducted prior to our decision regarding split State
status, since the find raised questions regarding testing and movement
standards and controls.
We agree with the commenters' initial point. As stated above,
Antrim County has been removed from the proposed modified accredited
advanced zone in this final rule and added to the modified accredited
zone. Subsequent to the finding of bovine tuberculosis in Antrim
County, a full investigation was conducted with no regulatory
violations found. In our view, the animal in question was incubating
the disease prior to its entry into Antrim County, testing negative at
the time of movement. It is to the credit of the Michigan bovine
tuberculosis eradication program that the animal was detected and
depopulated with no subsequent spread of the disease.
Several commenters stated that Michigan should first be required to
show progress in its bovine tuberculosis eradication program,
particularly in the areas of surveillance and control, before split
State status is granted.
We believe Michigan has shown marked progress in all areas of their
program. Discovery of the infected herd in Antrim County is a result of
Michigan's active surveillance and testing program. We agree that
movement control is critical to the success of split State status and
have communicated this necessity to the Michigan Department of
Agriculture. We have recently completed a review of the UMR and have
identified a number of pertinent changes regarding wildlife reservoirs
that we intend to consider in order to completely update the UMR. In
addition, APHIS is working in cooperation with the State of Michigan to
identify strategies that will allow us to isolate potentially infected
wildlife from domestic cattle herds. These developments will allow us
to realize more effective methods of bovine tuberculosis control.
One commenter said that the UMR needs to be reevaluated in order to
establish new standards related to bovine tuberculosis risk criteria.
As stated previously, we are in the process of revising the UMR.
New and more stringent standards are proposed for incorporation in
several areas, including those related to bovine tuberculosis
surveillance and the requirements necessary to achieve and maintain
each level of classification for freedom from bovine tuberculosis. We
expect to publish a proposed rule detailing these changes in the coming
months.
Zone Classification Requirements
Several commenters said that, if split State status is granted to
Michigan, APHIS should conduct an annual review of that State's
management of its areas of bovine tuberculosis classification.
The regulations at Sec. 77.4(b) state that retention of split
State status is subject to annual review by the Administrator. This
review is currently conducted in the form of the Annual State Report,
which incorporates followup, onsite State reviews when necessary. The
Annual State Report is a significant component of our determination of
a State's bovine tuberculosis status. Additionally, in order to retain
zone recognition, a State must continue to demonstrate its compliance
with Sec. 77.4(a)(1) through (a)(3) as well as the requirements for
maintaining or improving the tuberculosis risk classification of each
zone in the State, and retaining for at least 2 years all certificates
required for the movement of cattle, bison, and captive cervids.
Several commenters stated that bovine tuberculosis testing and
[[Page 20807]]
surveillance should be conducted to ensure that 100 percent of herds
within the modified accredited advanced area are tested within the 6-
year testing span.
The State of Michigan planned, and has nearly completed, a
statewide area test of all herds. Michigan has also upgraded its
slaughter surveillance. Further, Michigan is pursuing an active
surveillance strategy focused on quickly identifying infected herds
while they are still at a low level of infection via regular annual
testing of all herds in the modified accredited area. Based on our
research and experience, subsequent random sampling and surveillance
within the modified accredited advanced zone need only occur in 2-year
cycles. A continual policy of 100 percent testing within the modified
accredited advanced zone would prove both costly and inefficient.
Further, in the next 3 years, the State of Michigan has agreed to
implement a surveillance system with biased sampling, which would
weight areas based on the frequency of intrastate movements of cattle
from the modified accredited zone as well as their proximity to the
modified accredited zone. We have found that such targeted surveillance
programs prove most effective in quickly and accurately assessing a
State's bovine tuberculosis infection levels.
One commenter said that strict monitoring of intrastate cattle
movements should be a necessary component of operations for any State
with split status.
Under Sec. Sec. 77.3 and 77.4 of the regulations, in order to
qualify for zone classification, States must, among other things, adopt
and enforce regulations that impose restrictions on the intrastate
movement of cattle, bison, and captive cervids that are substantially
the same as those in place in part 77 for the interstate movement of
those animals. Michigan has implemented stringent identification and
intrastate movement permit requirements and is working in cooperation
with the Michigan Department of Transportation in order to monitor
these movements.
Two commenters suggested that untested cattle from the modified
accredited zone should be required to be moved only in sealed vehicles
accompanied by a VS-127 permit.
We typically require VS-127 permits only for transport of known
diseased animals or exposed animals. Control at this level would
involve a great amount of time, personnel, and expense for all affected
parties. As such, this approach is not cost effective. We believe that
the procedures currently in place, properly administered and executed,
will be adequate to reduce the risk of disease transmission to
acceptable levels.
One commenter said that all intrastate movement procedures should
be required to conform to a nationally applicable standard.
While APHIS does establish interstate movement requirements and, as
stated previously, require State intrastate movement regulations to be
substantially the same, the particulars of intrastate movement are
governed by State authorities. Establishment of the suggested national
standard would require a wide-ranging regulatory change, and is
therefore outside the scope of this rulemaking.
One commenter stated that the proposed change to split State status
will cause sizable economic harm to breeders as a result of increased
recordkeeping and registration requirements.
We are in the process of gathering data related to testing and
identification costs in order to reevaluate our current information on
those subjects. Our proposed rule contained a detailed analysis of the
potential costs to entities associated with the cattle industry in
Michigan, including breeders, wherein we determined that the proposed
action would not have a significant economic impact on a substantial
number of small entities. We consider ``significant impact'' to mean
that the cost of a given action is equal to or greater than the small
business's profit margin (5 to 10 percent of annual sales). By these
standards, given the size and profitability of the cattle industry in
Michigan, this action does not represent a significant impact on a
substantial number of small entities. Given that, currently, the entire
State of Michigan is classified as modified accredited for bovine
tuberculosis, those producers within the designated modified accredited
zone should experience no change in those costs associated with
interstate movement. A more detailed analysis of this issue can be
found later in this document under the heading ``Executive Order 12866
and Regulatory Flexibility Act.''
Movement to Slaughter
Two commenters discussed the need for recordkeeping, audits, and
information sharing to ensure that cattle and bison from the modified
accredited zone that are moving in slaughter channels are not diverted
for other purposes. One of those commenters stated that slaughter
facilities should be required to record identification information for
all such cattle and bison, and the other commenter asked what record
auditing was done at slaughter facilities that are not equipped with
electronic identification readers.
We agree that it is important to have checks in place to ensure
that cattle and bison moving in slaughter channels are not diverted for
other purposes. Traditionally, compliance activity in this regard has
been accomplished by investigating potential or reported diversions and
taking action in specific cases. Beyond that, there are simply not
enough Federal or State personnel available to track every animal in
slaughter channels to ensure that they are not diverted. As noted
previously, Michigan has implemented stringent identification and
intrastate movement permit requirements; those permit requirements
apply to animals moving to slaughter, so there is an opportunity to
confirm that all the animals listed on a permit arrive at the
slaughtering facility as intended. In federally inspected slaughtering
facilities, the U.S. Department of Agriculture's Food Safety and
Inspection Service collects all manmade identification and correlates
it with any blood or tissue specimens submitted for surveillance
testing purposes. We recognize that the level of record auditing at
various slaughtering facilities will not always be sufficient to
prevent or detect the diversion of animals from slaughter, and intend
to continue our work with State authorities in Michigan to make
improvements in this area.
A commenter said that, under split State status, it is necessary to
ensure that cattle from the modified accredited zone are moved directly
to slaughter facilities, without stopping.
The regulations currently require movement of cattle to be direct
to slaughter without offloading. These provisions are found at Sec.
77.10(a) with regard to shipments from modified accredited advanced
States or zones and at Sec. 77.12(a) with regard to shipments from
modified accredited States or zones.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register.
This rule establishes two separate zones with different
tuberculosis risk classifications in the State of Michigan and raises
the designation of one of those zones from modified accredited to
modified accredited advanced. This will
[[Page 20808]]
eliminate certain testing requirements for those cattle from the higher
status zone, thus reducing the burden on producers and veterinarians.
Therefore, the Administrator of the Animal and Plant Health Inspection
Service has determined that this rule should be effective upon
publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. For this
action, the Office of Management and Budget has waived its review under
Executive Order 12866.
Bovine tuberculosis is a communicable disease of cattle, bison,
cervids and other species, including humans, and results in losses of
meat and milk production among infected animals. As part of the
Cooperative State/Federal Tuberculosis Eradication Program, which has
virtually eliminated bovine tuberculosis from the Nation's livestock
populations, the regulations classify each State according to its
tuberculosis risk and place certain restrictions on the movement of
cattle and bison from States with high-risk classifications.
Previously, the State of Michigan was classified as modified
accredited for cattle and bison. We are amending the regulations to
establish two classification zones within Michigan. A zone consisting
of Alcona, Alpena, Antrim, Charlevoix, Cheboygan, Crawford, Emmet,
Montmorency, Oscoda, Otsego, and Presque Isle Counties and those
portions of Iosco and Ogemaw Counties that are north of the
southernmost boundary of the Huron National Forest and the Au Sable
State Forest is classified as modified accredited. The designation of
the remaining counties in the State is raised from modified accredited
to modified accredited advanced. We discuss below the projected
economic effects of this action.
On January 1, 2002, there were approximately 15,000 cattle
operations in Michigan, totaling 990,000 head of cattle. According to
the National Agricultural Statistics Service, in Michigan each head of
cattle is worth approximately $930, with a reported total cash value of
$920.7 million. Of the 15,000 operations, over 98 percent are
considered small entities under criteria established by the Small
Business Association. Consequently, this analysis of the economic
effects of the proposed rule change for the entire State is also
sufficient for analyzing the small entity impact.
The boost in status for all Michigan counties except those 13
counties listed previously, from modified accredited to modified
accredited advanced will result in fewer intrastate movement
restrictions and one less tuberculin test for interstate movement.
Decreased testing will result in decreased production costs for those
producers in those areas whose status is raised to modified accredited
advanced, thus providing a monetary benefit. As such, this analysis
will focus on the cost savings of testing cattle and bison for movement
captured by those elevated to modified accredited advanced status.
For those 13 counties that will retain modified accredited status,
there will be no change in production costs. These 13 counties
contribute approximately 69,600 head of cattle to the statewide total,
representing only 7 percent of total cattle production in Michigan.
Consequently, the benefits of this regulation will be realized by the
majority of producers in the State.
An official tuberculin test for an average herd is about $380,
which equates to approximately $6.33 per animal based on an average
herd size in Michigan of 60 animals. The cost savings of the tuberculin
test are not economically significant to cattle and bison producers.
Considering that, on January 1, 2002, the average value per head of
cattle was $930, the cost savings of reduced testing represent less
than 1 percent of the per head value. In general practice we assume a
regulation that has compliance costs which equal a small business'
profit margin, or 5 to 10 percent of annual sales, pose an impact which
can be considered ``significant.''\1\ For the purposes of illustration
and analysis of the small entity impact, if we assume a cattle producer
owns only 1 average herd of about 60 animals, with annual sales of
approximately $56,000, compliance costs totaling between $2,800 and
$5,600 would qualify as posing a ``significant'' economic impact on
this entity. In the case of cattle producers in Michigan, the average
compliance costs of TB testing for an entire herd would total about
$380. Thus, for producers located in counties whose status will be
raised to modified accredited advanced, the cost savings from reduced
testing, while beneficial, will not represent a significant monetary
savings. Of course, the more a particular herd owner is involved in
interstate movement, the greater the cost savings will be.
Unfortunately, the exact number of herd owners involved in interstate
movement is unknown. However, it is clear that this change in status
will not represent an economically significant benefit for those
producers operating in counties whose status is raised to modified
accredited advanced. This final rule will constitute no change in
operational procedures for those counties that will remain under
modified accredited status.
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\1\ Verkuil, Paul R. ``A Critical Guide to the Regulatory
Flexibility Act,'' Duke Law Journal, Apr. 1982: 928.
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Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 77
Animal diseases, Bison, Cattle, Reporting and recordkeeping
requirements, Transportation, Tuberculosis.
0
Accordingly, we are amending 9 CFR part 77 as follows:
PART 77--TUBERCULOSIS
0
1. The authority citation for part 77 is revised to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 77.9 is amended by revising paragraph (b) to read as
follows:
Sec. 77.9 Modified accredited advanced States or zones.
* * * * *
(b) The following are modified accredited advanced zones: All of
the State of Michigan except for the zone that comprises those counties
or
[[Page 20809]]
portions of counties in Michigan described in Sec. 77.11(b).
* * * * *
0
3. Section 77.11 is amended by revising paragraphs (a) and (b) to read
as follows:
Sec. 77.11 Modified accredited States or zones.
(a) The following are modified accredited States: None.
(b) The following are modified accredited zones: A zone in Michigan
that comprises Alcona, Alpena, Antrim, Charlevoix, Cheboygan, Crawford,
Emmet, Montmorency, Oscoda, Otsego, and Presque Isle Counties and those
portions of Iosco and Ogemaw Counties that are north of the
southernmost boundary of the Huron National Forest and the Au Sable
State Forest.
* * * * *
Done in Washington, DC, this 13th day of April, 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-8751 Filed 4-16-04; 8:45 am]
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